Measure of Vaccine Effectiveness to Prevent Hospitalizations for Viral Respiratory Infections in Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,400
- 试验地点
- 5
- 主要终点
- Vaccine effectiveness
研究概览
简要总结
This study is a prospective, multicentric, observational test negative design study on adults hospitalized for Severe Acute Respiratory Infection (SARI), regardless of their vaccination status.
详细描述
Participation to the study will be systematically proposed to all patients hospitalized fitting inclusion criteria. Patient's screening will be done in emergency department or hospital department with direct admission. Medical investigators explain the objectives of the studies, procedure and propose the patient to participate in the study. Socio-demographic data, clinical and virological data will be collected in an electronic clinical research form.
A follow-up at 1 and 3 months after hospitalization discharge will be scheduled to evaluate health status.
The remainder of respiratory samples that have been performed for care will be used for further testing depending on epidemiological situation and will be stored at -80°C.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old
- •Admitted in a hospital for at least 24 h
- •Presents SARI criteria within onset within the last 14 days before sampling and less than 48 h after hospitalisations:
- •At least one of the following signs (without treatment): fever or feverishness, malaise, headache, myalgia or sign of fatigue (loss of weight or anorexia or confusion or dizziness) Associated with at least one respiratory symptom or sign (cough, sore throat or shortness of breath; or tachypnoea or signs of low oxygen saturation)
- •completed non-opposition form
- •Respiratory samples within 14 days after symptoms onset, in the context of care
排除标准
- •Contraindication of vaccination
结局指标
主要结局
Vaccine effectiveness
时间窗: up to 48 hours
Comparison of the number of virologically confirmed cases of vaccine preventable Severe Acute Respiratory Infections (SARI) among hospitalized vaccinated patients compared with unvaccinated patients.
次要结局
- Influenza vaccine effectiveness(up to 48 hours)
- Covid-19 vaccine effectiveness(up to 48 hours)
- Prevalence of viral and bacterial co-infections(up to 48 hours)
- Incidence of SARI by site(up to 12 months)
- Clinical burden of SARI(up to 3 months)